Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-11-30

Brief Summary

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Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and infection sets in around the diverticulum the condition is called diverticulitis. An individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent hospitalisations as a result of the evolution of purulent peritonitis that originates from diverticulitis treated by mini-invasive surgery results.

Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic generalized purulent peritonitis of diverticular origin have been identified as therapeutic options by HAS (French health authorities), followed by second stage resection-anastomosis under elective surgery. It has been observed in patients that if only drainage and washing are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore this reduces the risks of postoperatory complications.

Some studies have shown that the attitude of non-distance resection of the acute episode was associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity. In addition, the morbidity associated with intervention sigmoid resection is around 30%.

The question arises in our daily practice, or not to propose systematic resection of sigmoid diverticulitis after an acute episode of severe purulent peritonitis or abscess types supported initially by minimally invasive.

The primary objective of the study is to determine, after clinical improvement linked to conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as currently recommended.

The secondary objective of the study is to determine if conservative treatment reduces mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and improves quality of life.

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Detailed Description

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Conditions

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Peritonitis Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sigmoidectomy arm

Standard of care arm : sigmoid reserction after randomisation

Group Type OTHER

Surgical reserction

Intervention Type PROCEDURE

Control arm

laproscopic drainage and washing

Group Type EXPERIMENTAL

Radiological percutaneous drainage and washing drainage

Intervention Type OTHER

Interventions

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Surgical reserction

Intervention Type PROCEDURE

Radiological percutaneous drainage and washing drainage

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have had an episode of sigmoid diverticulitis as a result of pelvic or purulent peritonitis (Hinchey stage II and III) complications and treated by conservative treatment such as per cutaneous radiological drainage or laparoscopic-assisted per cutaneous drainage.
* Male and female individuals aged from 18 to 65 years old (both ages included).
* Absence of contra-indication for surgery ASA Score ≤3
* Participants must have signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
* Patients will sign an informed consent after haven been informed of the results of the previous medical visit.
* Patients must be affiliated with, or a beneficiary of a social security system

Exclusion Criteria

* Subjects in the exclusion period (haven participated in a previous trial or an ongoing trial )
* Contra- indication to surgery
* ASA Score \>3
* Past history of evolutive neoplasm,
* Subjects unable to consent (case of emergency, subjects having difficulties in understanding)
* Patients for which consultation visits will not be possible (e.g. tourists and people who cannot stay above 18 months in France).
* Pregnant and breastfeeding women
* Subjects under tutorship or curator ship
* Subjets under judicial protection

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine ARVIEUX, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217

Cécile BRIGAND, MD, PHD

Role: STUDY_CHAIR

Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex

Sébastien DAN, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec

David GUINIER, MD

Role: PRINCIPAL_INVESTIGATOR

Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient

Mehdi KAROUI, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil

Christophe MARIETTE, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex

MSIKA Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes

MUSCARI Fabrice, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX

Marc POCARD, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10

REGIMBEAU Jean Marc, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens Nord Place Victor, Pauchet 80054 Amiens

Didier RIO, MD

Role: PRINCIPAL_INVESTIGATOR

Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes

Karim SLIM, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt

Bertrand SUC, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX

Locations

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